New Analytical HPLC Method Development and Validation for the Simultaneous Quantification of Paritaprevir Ombitasvir and Ritonavirin Spiked Human Plasma.

R.S.Ch, Phani; Prasad, K. R. S.; Mallu, Useni Reddy

doi:10.13005/ojc/330528

Cited by 7 publications

(4 citation statements)

References 5 publications

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“…Literature review revealed that few methods were reported for the simultaneous determination of OMB, PAR, and RIT, all based on chromatographic analysis techniques. Eight papers described High Performance Liquid Chromatography (HPLC) methods using isocratic mobile phase 6–13 and two Ultra‐High Performance Liquid Chromatography (UHPLC) methodologies were reported utilizing MS/MS detection 14,15 . No UV spectroscopic methods were reported for the simultaneous determination of the three antiviral drugs under study.…”

Section: Introductionmentioning

confidence: 99%

Chemometry‐assisted UV‐spectrophotmetric methods for the simultaneous determination of paritaprevir, ritonavir, and ombitasvir in their combined tablet dosage forms: A comparative study

Sayed

Ibrahim

Sharaf

2021

Journal of Chemometrics

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The ternary mixture under study is a recent hepatitis‐C antiviral medicine composed of three new directly acting antiviral drugs, namely, ombitasvir, paritaprevir, and ritonavir. They are co‐formulated as a single‐dose combined tablet dosage form. With more than 170 million infected patients worldwide, a large production scales of antivirals medicine is expected, and hence, new simple and fast methodologies are required to cover millions of analyses that are done routinely in the different pharmaceutical quality control and research laboratories. Ultraviolet spectrophotometry represents sensitive, fast, and cheap tool of analysis in all research and quality control laboratories that can cover the massive quality control of these regimens. However, the simultaneous determination of these three drugs using multivariate chemometric methods represents a high challenge as their spectra are strongly overlapping besides the large difference in their potency within the same tablet. In this research paper, four new different multivariate chemometric methods were developed for their simultaneous determination, namely, classical least square (CLS), principal component regression (PCR), partial least squares (PLS), and genetic algorithm‐partial least squares (GA‐PLS) techniques. The validated methods do not require extraction, separation, or derivatization steps. A comparative study was conducted among the four developed methods. All methods provided satisfactory results, whereas GA‐PLS showed better analytical performance as it had the lowest error with good higher correlation coefficient. The methods were applied in the simultaneous determination of the three drugs in pure form and in their combined tablet dosage form. The comparison confirmed agreement of the values obtained for all techniques.

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Section: Introductionmentioning

confidence: 99%

Chemometry‐assisted UV‐spectrophotmetric methods for the simultaneous determination of paritaprevir, ritonavir, and ombitasvir in their combined tablet dosage forms: A comparative study

Sayed

Ibrahim

Sharaf

2021

Journal of Chemometrics

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“…To our knowledge, only four research methods were reported using HPLC. Three methods used acetonitrile (ACN) as organic modifier in proportion higher than 60% in the isocratic mobile phase [6, 7, 8] and one method used a 40% combination of methanol and ACN as organic modifier [9]. Two UHPLC methods were reported using MS/MS detection [10, 11].…”

Section: Introductionmentioning

confidence: 99%

Development and validation of eco-friendly micellar-HPLC and HPTLC-densitometry methods for the simultaneous determination of paritaprevir, ritonavir and ombitasvir in pharmaceutical dosage forms

Ibrahim

Saraya

Saleh

et al. 2019

Heliyon

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Ombitasvir, ritonavir and paritaprevir are three recently discovered directly acting antiviral drugs (DAADs) used in combined single dose tablet dosage form for treatment of hepatitis-C viral infections (HCV). The methods of analysis followed by quality control and research laboratories are required to be economic and fast; however, these methods can also produce huge amounts of chemical waste. In this study two fast, economic and green HPLC and HPTLC methods were validated for the simultaneous determination of the three drugs. For HPLC, isocratic elution used a mixture of micellar aqueous mobile phase consisting of (0.15 M sodium lauryl sulfate and 0.01 M sodium dihydrogen phosphate, pH 6.2) and ethanol (56:44). Elution was done on RP-C18 Kinetix® column (5 μm, 150 mm × 4.6 mm ID) at flow 1 mL min -1 and 254 nm UV-detector. HPTLC separations were performed on Merck® (20 cm × 10 cm) aluminum HPTLC plates coated with silica gel 60F254 using a mobile phase, Methylene chloride: methanol: ethyl acetate: ammonia (25%), (5:1:3:1, v/v/v/v) respectively. The calibration curves were linear across ranges of 3–100 μg mL -1 and 0.1–2 μg/spot for both HPLC and HPTLC methods, respectively. The two methods were applied successfully for the determination of the three drugs under study in their combined tablets dosage forms.

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“…The combination of studied drugs is not listed in any pharmacopoeia. Literature survey revealed that there are only two number of HPLC methods for the quantification of selected drug combination [9,10]. An RP-HPLC method for the determination of ombitasvir, paritaprevir and ritonavir in bulk and its dosage forms was presented by Srinivas and Yadagiriswamy [9].…”

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confidence: 99%

“…The retention times for ombitasvir, paritaprevir and ritonavir were 2.315 min, 2.89 min and 5.483 min, respectively. Phani et al [10] determined ombitasvir, paritaprevir and ritonavir in spiked human plasma by HPLC with UV detection at 230 nm using an Intersil ODS C18 analytical column and a mobile phase consisting of acetonitrile, methanol, 1 mM NH4H2PO4 buffer (20:20:60 v/v/v, pH 6.5). The retention times of ritonavir, ombitasvir and paritaprevir are 5.7 min, 7.8 min and 12.8 min, respectively.…”

mentioning

confidence: 99%

Stability-Indicating RP-HPLC Method for Simultaneous Quantification of Ombitasvir, Paritaprevir and Ritonavir in Tablet Dosage Form

Kuna¹,

Dannana²

2018

Asian J. Chem.

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A new stability indicating RP-HPLC method has been developed for simultaneous estimation of ombitasvir, paritaprevir and ritonavir in bulk and tablet dosage form. The method involves separation and analysis of the selected drugs on Inertsil ODS C18 (4.6 mm × 250 mm, 5 µm). The optimized mobile phase consists of orthophosphoric acid (40 %): acetonitrile (60 %) with a flow rate of 1 mL/min and detection at 252 nm. Retention time was 2.056 min for ombitasvir, 2.821 min for paritaprevir and 4.853 min for ritonavir. The developed method was validated as per the ICH guidelines. Linearity was observed in the range of 6.25-31.25 µg/mL for ombitasvir, 37.5-187.5 µg/mL for paritaprevir and 25-125 µg/mL for ritonavir with good correlation coefficient value (> 0.9990). The percentage recoveries of ombitasvir, paritaprevir and ritonavir were in the range of 99. 98-100.69 %, 99.16-100.75 % and 99.82-100.08 %, respectively. The percentage relative standard deviation was < 2 %. The method had the ability to quantify the drugs simultaneously from tablets dosage forms with no interference from the tablets excipients. Ombitasvir, paritaprevir and ritonavir were also subjected to acid, base, oxidation and thermal degradation studies. The proposed method effectively analyzed the studied drugs in the presence of their degradation products.

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New Analytical HPLC Method Development and Validation for the Simultaneous Quantification of Paritaprevir Ombitasvir and Ritonavirin Spiked Human Plasma.

Cited by 7 publications

References 5 publications

Chemometry‐assisted UV‐spectrophotmetric methods for the simultaneous determination of paritaprevir, ritonavir, and ombitasvir in their combined tablet dosage forms: A comparative study

Chemometry‐assisted UV‐spectrophotmetric methods for the simultaneous determination of paritaprevir, ritonavir, and ombitasvir in their combined tablet dosage forms: A comparative study

Development and validation of eco-friendly micellar-HPLC and HPTLC-densitometry methods for the simultaneous determination of paritaprevir, ritonavir and ombitasvir in pharmaceutical dosage forms

Stability-Indicating RP-HPLC Method for Simultaneous Quantification of Ombitasvir, Paritaprevir and Ritonavir in Tablet Dosage Form

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